ATK HPV

Primary DI

06260001187795

Basic UDI-DI Code

62600011ATK.HPV4D

Reference

ATK.R011

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Arghavan Teb Kavian

The kit is designed for the detection and screening of high-risk genotypes of Human Papillomavirus (HPV) in human cervical Pap smear samples.The Arghavan Teb Kavian HPV Genotyping and Screening Kit is based on Real-Time PCR technology, targeting the E6 and E7 gene regions of the pathogen using specific TaqMan probes for HPV detection. During Real-Time PCR, the amplified product is identified using fluorescent dyes attached to oligonucleotide probes that specifically bind to the amplified product during thermocycling. Monitoring the fluorescence intensity in real-time during the PCR process allows for the detection of accumulated product without reopening the reaction tubes post PCR. This multiplex Real-Time PCR method simultaneously amplifies DNA fragments of 14 HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). Analysis is performed in three tubes to detect the presence of these 14 HPV DNA types. Each genotype is detected in a separate fluorescence channel, enabling not only detection but also genotyping of high-risk HPV types. The human gene P(RNase) is included in the reaction tube as an internal control. The internal control should always be present in sufficient quantity in the sample (cervical Pap smear) to match the number ofcells in the swab. Thus, the internal control monitors not only the test procedures (DNA extraction and Real-Time PCR amplification) but also evaluates the adequacy of sample collection and storage of clinical materials. If the sample is improperly collected (insufficient epithelial cells), the amplification signal of the β-globin gene will be underestimated.Additionally, an external plasmid control, puc57, is used to assess the quality of the extracted DNA.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).